This invention relates to surgical appliances and methods, and more particularly to an improved apparatus and method for perfusion and lavage of an abdomino-pelvic area both during and after surgery; and in particular when using cell-cycle specific chemotherapy drugs which require long-term contact with tissues in order to achieve their optimal effect. By allowing prolonged and repeated access to an abdominal cavity the apparatus can assist in the management of serious intra-abdominal infections. Additionally, by permitting repeated access to the abdominal cavity, the apparatus is adapted for non-oncologic use in the treatment of intra-abdominal sepsis, peritonitis and pancreatitis.
One of the mechanisms of the dissemination of gastrointestinal and gynecologic cancers is the intraperitoneal dissemination of the disease. Without special treatments all patients with peritoneal dissemination of cancer die; most patients die within one year. In an attempt to improve the control of intra-abdominal cancer, large doses of anti-cancer drugs can be injected directly into the peritoneal cavity. This therapy has shown beneficial effects in selected patients. Also other therapies in addition to intraperitoneal chemotherapy have been developed in an effort to better control the peritoneal dissemination of cancer.
It has been observed that hyperthermia seems to have a direct anti-cancer effect and synergy with some types of anti-cancer drugs, so that the toxicity for cancer cells is significantly increased at an elevated temperature. Examples of chemotherapy drugs which have been found effective in hyperthermic perfusion of the peritoneal cavity are cisplatin (CDDP) and mitomycin C (MMC). Accordingly, hyperthermic peritoneal lavage with a chemotherapy solution has been utilized to wash away free cancer cells in the peritoneal cavity by irrigation with a large volume of perfusate, to kill cancer cells by hyperthermia, and to kill cancer cells by the direct effects of chemotherapy. However, due to the inherent long and short term toxicity of chemotherapy solutions to operating room personnel, lavage with a chemotherapy solution can only be safely performed in a contained environment that prevents splashing, spillage and aerosol contaminants from escaping into the local atmosphere creating an environmental hazard to health care personnel.
Conventional techniques employing hyperthermic peritoneal lavage rely upon the use of a tube for infusion of heated fluid into the peritoneal cavity, and one or more drain tubes for removing the perfusate from the cavity. The lavage fluid can contain acid to lower pH, sugar to elevate glucose levels, antibiotics, chemotherapy (using single or multiple agents) and fibrinolytic agents, and can be exchanged to irrigate away cancer cells, fibrinous debris and other intra-abdominal contaminants. The tubes can be inserted through small stab incisions formed in a wall of the abdomen and guided by the surgeon into a general anatomic site in which irrigation is desired, or the surgeon can make a larger incision and visually place the tubes for appropriate irrigation of the peritoneal cavity.
Direct manipulation of the tubes and of the patient""s viscera during chemotherapy perfusion of the abdomino-pelvic cavity in order to guarantee uniform distribution is impossible with the conventional stab-incision technique due to the lack of access to the patient""s abdomino-pelvic cavity which is afforded to the surgeon. Although direct manipulation of the tubes and viscera may be accomplished in circumstances where large incisions are employed, the inability of these conventional open abdomen techniques to contain and prevent spillage of inherently toxic lavage fluid and its aerosols thus presents a significant risk of contamination of the surgical environment with a resultant unacceptable risk of exposure of health care personnel to toxic substances.
Heated intraperitoneal chemotherapy is used to bring as much dose intensity to the affected abdominal and pelvic surfaces as is possible. Heat by itself has been shown to have a greater toxicity for cancerous cells than for normal tissues. Heat also increases the penetration of chemotherapy into tissues. As the tissues soften in response to the heat the elevated interstitial pressure of a tumor mass may decrease thereby allowing improved drug penetration. Furthermore, heat increases the cytotoxicity of selected chemotherapy agents. This synergism occurs only at the interface of heat and body tissue, at the peritoneal surface. However, in conventional techniques the temperature of the lavage fluid is typically monitored on the inflow and outflow tubes but not throughout the peritoneal cavity, thereby reducing the accuracy of control over temperature and thus possibly increasing the danger of heat injury and reducing the effectiveness of the hyperthermic treatment.
The effectiveness of hyperthermic abdomino-pelvic perfusion using conventional techniques is further reduced because the heated chemotherapy solutions may not reach cancer cells between adherent surfaces in the deep areas of the peritoneum or mesenterium, and thus the perfusate incompletely eradicates cancer cells within the peritoneal cavity.
Moreover, assessment of the efficacy of treatments for peritoneal surface cancer by measuring the ascites volume or imaging a layer of cancer by computer tomography or ultra-sonography or the cytologic examination of ascites is remarkably ineffective in revealing residual or recurrent cancer in the peritoneal cavity.
Additionally, the inability to contain the environment within which conventional abdomino-pelvic perfusion is performed for an extended period of time further reduces its effectiveness because it limits or precludes the ability to use cell-cycle specific drugs such as 5-fluorouracil, which achieve their optimal effect through continuous long-term exposure of 5-10 days.
There are limited diagnostic methods available to establish the occurrence of peritoneal dissemination of cancer. In most patients, this pattern of dissemination is seen at the time of surgical removal of the primary gastrointestinal or ovarian cancer. In a small proportion of patients, the peritoneal recurrence of cancer can be imaged by abdominal computerized tomography. In other patients, the rise in a tumor marker can lead to the diagnosis of peritoneal dissemination. In some situations, a second look operation (SLO) is the only reliable procedure to assess the disease state of the cancer patient.
The SLO was introduced into gastrointestinal and gynecologic surgery to provide an oncologist with a means for assessing the status of the disease approximately one year after the initial operation, before advanced disease has occurred and before the reactivation of symptoms. In gynecology, especially, SLO has been gradually approved as a useful means for assessing tumor response, removing recurrent cancer, and planning subsequent treatment in the follow-up of patients with ovarian cancer.
In order to overcome at least some of the shortcomings of prior techniques, while at the same time taking advantage of the beneficial effect of intraperitoneal chemotherapy and hyperthermia in cancer therapies, a method and apparatus for continuous hyperthermic peritoneal perfusion in combination with the administration of anti-cancer drugs having synergism with hyperthermia was developed, and disclosed, in Takashi Fujimura, et al., xe2x80x9cContinuous Hyperthermic Peritoneal Perfusion for the Treatment of Peritoneal Dissemination in Gastric Cancers and Subsequent Second-Look Operationxe2x80x9d, Cancer 65:65-71, 1990. Other similar methods and apparatuses are disclosed in Sugarbaker, U. S. Pat. No. 5,336,171, the contents of which is specifically incorporated herein in its entirety by reference, and Sugarbaker, xe2x80x9cManagement of Peritoneal Surface Malignancy using Intraperitoneal Chemotherapy and Cytoreductive Surgeryxe2x80x9d, The Ludann Company, November 1998, the entire contents of which is also incorporated herein by reference. Neuman, et al., U.S. Pat. No. 5,437,683, also discloses an apparatus for repeatedly opening and closing an abdominal incision for repeated lavage of the intra-abdominal cavity.
The apparatus developed by Fujimura, et al., comprises an acrylic cylinder with a flange at each end. One of the flanges is positioned inside the abdominal wall and the other is suspended from two right-angled bars fixed to an operating table. The cylinder is open-ended and is fixed in the surgical wound made by the surgeon. It is large enough to permit the small intestine to float in the perfusate which is a heated chemotherapy solution infused into the peritoneal cavity. Tubes extend into the peritoneal cavity through the cylinder are used to introduce and remove perfusion fluid from the cavity.
Although the Fujimura, et al. apparatus solved some of the problems of prior art systems and techniques, it is intended for use only in an operating room environment while the perfusion procedure is being performed and consequently precludes use of chemotherapy agents which achieve their optimal effect through long-term contact with the tissues. It does not protect against seepage of chemotherapy solution between the acrylic cylinder and the skin. Additionally, no protection of operating room personnel from splashing, spillage or aerosols is provided.
The Sugarbaker apparatus disclosed in U.S. Pat. No. 5,336,171 is adapted to be secured in a midline abdominal incision, and comprises an open-ended cylindrical wall having an upper end projecting above the abdominal wall and a base end with means for securing and sealing the apparatus to the skin surrounding the abdominal incision, in a water-tight manner, to form a well for containing the lavage fluid used to treat the surfaces of the abdomen and pelvis. Heated lavage fluid under pressure with anti-cancer drugs are added until the abdominal and pelvic cavities are completely filled with the fluid. Although this apparatus solved some of the additional problems of prior art systems and techniques, the seals joining the apparatus to the skin surrounding the surgical incision failed to safely secure the apparatus in place and thus presented a risk of spilling the lavage fluid with consequent exposure of personnel to the chemotherapy fluids and aerosols.
The Neumann apparatus disclosed in U.S. Pat. No. 5,437,683 is likewise adapted to be secured in an abdominal incision and comprises a fabric of plate-like securing elements that can be detachably connected to the body tissue and has a closure that can be repeatedly opened and closed. This apparatus is an adaptation of a zipper technique which seeks to provide a convenient means for the repeated opening and closing of the surgical site. This apparatus, however, is not adapted to accommodate chemotherapy lavage and thus is inapplicable for continuous hyperthermic peritoneal perfusion in combination with the administration of anti-cancer drugs having synergism with hyperthermia.
The Sugarbaker method and apparatus disclosed in xe2x80x9cManagement of Peritoneal Surface Malignancy using Intraperitoneal Chemotherapy and Cytoreductive Surgeryxe2x80x9d, involves heated intraoperative intraperitoneal chemotherapy by an open technique characteristic in that a running monofilament suture is used to secure the skin edges surrounding an abdominal incision to a self-retaining retractor. A tent-like plastic sheet is incorporated into the sutures to create an open space beneath. A slit is made in the plastic cover to afford the surgeon""s hands access to the abdomen and pelvis whereby the surgeon can manipulate the viscera during the perfusion with the result that all of the anatomic structures within the peritoneal cavity are exposed to heat and to chemotherapy. Although this latter method and apparatus further solved some of the problems of prior art systems and techniques, the self-retaining retractor and tent-like plastic sheet preclude the ability to selectively and repeatedly open and close access to the abdomino-pelvic cavity, and to reliably prevent spillage of perfusion fluid or infiltration of the fluid""s aerosols into the surrounding operating room environment, and thereby also limit its safe use. Thus, it too precludes post-operative lavage coupled with the administration of intraperitoneal chemotherapy agents which achieve their optimal effect through long-term contact with the tissues.
Accordingly, there is a need for an abdomino-pelvic perfusion and lavage apparatus which is supported by an operating room table or bed upon which a patient is lying and which is sealed to the patient""s anterior skin surface. It must allow for simple and secure suspension of the skin surrounding an incisional wound made through the abdominal wall. It must supply couplings for quick and easy connection of inflow and outflow tubes and temperature monitors through the wall of the apparatus. There is also a need that such an apparatus be capable of being left in place after the patient leaves the operating room so that continuous perfusion or repeated lavaging can be performed in an aseptic condition using cell-cycle specific chemotherapy agents which require long-term contact with the target tissues. Similarly, it is desirable that such an apparatus facilitate periodic manipulation of abdominal and pelvic contents and treatment in a surgical intensive care unit (SICU) without necessitating a further operation or even requiring further use of the operating room except to suture the abdomen closed. It is also desirable that the apparatus be sealable so that chemotherapy can be performed without danger of exposure of operating room and SICU personnel to chemotherapy aerosols. Moreover, a further desired feature would include openings for free access to the peritoneal cavity for both visual inspection and for the introduction of a surgeon""s hands for manipulation of the viscera. It is also desirable that there be couplings for quick and easy mounting of an air evacuation system which can evacuate the chemotherapy aerosols when the appliance is opened.
Furthermore, since chemotherapy not only directly destroys tumor cells but also eliminates viable platelets, neutrophils and monocytes from the peritoneal cavity; the ability of the abdomen to resist infection is reduced. Thus, it is imperative that the apparatus be adapted to maintain a strict aseptic environment when administering chemotherapy, handling abdominal tubes and drains, and during manipulation of the viscera.
The present invention is directed to an improved abdomino-pelvic perfusion and lavage apparatus adapted for use both during and after surgery and to which skin surrounding an incision formed through an abdominal wall of a patient can be attached and suspended. More particularly, the invention relates to an abdomino-pelvic perfusion and lavage apparatus for intraperitoneal treatment of diseases disseminated through the peritoneal cavity, and especially in the hyperthermic treatment of the peritoneal dissemination of gastrointestinal, ovarian and other intra-abdominal cancers. The invention especially allows the use of heat, coupled with manipulation of the organs, in peritoneal perfusion procedures and more particularly is adapted to be left in place after the patient leaves the operating room so that repeated lavaging can be performed using cell-cycle specific chemotherapy agents which require long-term contact with the target tissues. Additionally, by permitting repeated access to the abdominal cavity, the apparatus is adapted for nononcologic use in the treatment of intra-abdominal sepsis, peritonitis and pancreatitis.
In one preferred embodiment the invention comprises a containment vessel impermeable to water and air, having a wall having a base, wherein the wall has an upper end with a perimeter edge which defines an upper opening, a lower end with a perimeter edge which defines a base opening, a cranial end with a perimeter edge which defines an opening, and a caudal end with a perimeter edge which defines an opening. A plurality of fluid ports which are capable of providing hydraulic and pneumatic communication through the wall of the containment vessel are also provided. The containment vessel is adapted to be carried by a table on which the patient is positioned.
A further aspect of the invention comprises a scaffolding that is carried by the containment vessel for supporting and elevating the skin surrounding the incision made through the abdominal wall of the patient whereby said elevated skin forms a well above, and extending into, an abdomino-pelvic cavity.
A further aspect of the invention comprises a fluid supply reservoir which serves as a source for the perfusion fluid; a first pump in hydraulic communication with the fluid supply reservoir and at least one fluid port for providing the perfusion fluid from the source to the containment vessel; a second pump in hydraulic communication with the fluid supply reservoir and at least one fluid port for returning the perfusion fluid from the containment vessel back to the source; a heater in thermal communication with a fluid containing means to heat the perfusion fluid to a temperature of about 30xc2x0 C. to about 50xc2x0 C. during use of the containment vessel in hyperthermic peritoneal perfusion; at least one inflow tube in hydraulic communication with the fluid port receiving the perfusion fluid from the source for providing the perfusion fluid to the well formed in the patient""s abdomino-pelvic cavity; at least one drain tube in hydraulic communication with the fluid port returning the perfusion fluid to the source and having a distal intake end extended into the well in the patient""s abdomino-pelvic cavity for providing the perfusion fluid from the well; at least one temperature sensor positioned in proximity with the distal intake end of the drain tube and in communication with a thermostatic control in communication with the heater.
A further aspect of the invention comprises at least one removable cover capable of being secured and sealed over the upper opening of the containment vessel to enclose the well formed therein, thereby forming a barrier to aerosols so that chemotherapy agents can be used without exposing personnel to chemotherapy aerosols, and whereby the containment vessel may be left in place on a patient who may then be returned to an intensive care unit for follow-up examinations, continuous perfusion and repeated lavaging without introducing bacterial pathogens and without necessitating use of the operating room.
A further aspect of the invention comprises an air evacuator connected in pneumatic communication with one or more fluid ports to form a low air pressure gradient across the upper opening and thereby evacuate aerosols and gases from within the interior space whenever one or more of the sealable covers is open and thereby minimizing the risk of exposure of surgical and SICU personnel to the chemotherapy aerosols and gases.
A further aspect of the invention comprises a plurality of port-seals for sealing hydraulic and pneumatic communication through any unused fluid ports. A cranial opening seal is also provided to seal hydraulic and pneumatic communication through the cranial opening between the containment vessel and a torso of the patient and a caudal opening seal is likewise provided to seal hydraulic and pneumatic communication through the caudal opening between the containment vessel and a torso of the patient. A base seal is provided to seal hydraulic and pneumatic communication between the containment vessel and the table.